HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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The European Commission released version 5.0 of the EUDAMED Data Dictionary. This document provides an overview of the data fields and corresponding definitions that are to be provided to Eudamed and that can be communicated through the Data Exchange process for the UDI/Device module. To view the the EUDAMED Data Dictionary V5.0 click here. To.. read more →
The HIBC Basic UDI-DI satisfies the Basic UDI-DI requirements in the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The HIBC Basic UDI-DI enables manufacturers to connect and identify devices with the same intended purpose, risk class and essential design and manufacturing characteristics. The Basic UDI-DI is required in the EU’s EUDAMED.. read more →
Organizations applying for a HIBCC Labeler Identification Code (LIC) are required to complete the authorized application form on this website. This requirement is for quality control purposes and to assure the labeler information that we provide to regulatory authorities is accurate and derived from the original applicant. LIC application information obtained indirectly from other sources.. read more →
European Commission confirms two year delay for the launch of EUDAMED. Labeling deadlines are not affected by this delay.
The European Commission announced that EUDAMED’s launch will be done together for medical and in-vitro devices, at the original date for the in-vitro medical devices, May 2022. Previously EUDAMED was planned to launch in May 2020 for medical devices. The date of application of the Medical Device Regulation (MDR) remains May 2020. To view the.. read more →
The HIBC UDI-Builder is now available. This tool will allow you to create, calculate, confirm, and collect UDIs.
Create HIBC UDIsThe HIBC UDI-Builder’s intuitive, easy-to-use design assists users in quickly creating their UDIs. This on line utility will generate a UDI from the product information you enter. In combination with your HIBCC LIC the Creator tool will provide you with the correct data format for printing on packages and to meet FDA-required uploads.. read more →
European Union Medical Device Coordination Group (MDCG) releases document concerning the validity of existing certificates
Devices with existing certificates will remain valid until May 27, 2024. However, there are specific conditions that existing certificates, and the related devices, must comply with. The MDCG has released a document that outlines these conditions. To view the full document click here. To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly.. read more →
- 15 Jun 2020Register now for our HIBCC UDI Webinar
- 03 Jun 2020MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR
- 28 May 2020United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
- 26 May 2020FDA UDI labeling and database submission deadline for Class I and unclassified devices rapidly approaching.
- 29 Apr 2020European Commission publishes guidance document on regulatory requirements for ventilators